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Comparative Study
. 2021 Mar;24(1):90-101.
doi: 10.1007/s10047-020-01216-6. Epub 2020 Oct 20.

Comparison of supportive regulatory measures for pediatric medical device development in Japan and the United States

Sara Takahashi  1   2 , Kiyotaka Iwasaki  3   4   5 , Haruki Shirato  6 , Mami Ho  6 , Mitsuo Umezu  7   8   9
Affiliations
Comparative Study

Comparison of supportive regulatory measures for pediatric medical device development in Japan and the United States

Sara Takahashi et al. J Artif Organs. 2021 Mar.

Abstract

Further development of medical devices for children is required in Japan, but the development of such devices is delayed compared to that of medical devices for adults. Herein, we investigated policies for advancing the development of pediatric medical devices in Japan and the United States. Considering the achievements of each policy, we proposed a strategy to promote further development of pediatric medical devices in Japan. We investigated policies for supporting the development of pediatric medical devices and approved cases in Japan and the United States by searching contents of websites of regulatory bodies and other related administrations, and scientific papers. We found the main six policies in Japan and nine main policies in the United States for the development of pediatric medical devices. In the United States, various measures have initiated mainly in the 2000s, while in Japan, the main measures have been in place since 2013. Similarities were found in both countries, such as subsidies for application fees and research and development expenses, exemption of requirements for regulatory approval, and priority review and consultation by the regulatory body. Our study revealed that there are similarities in initiatives by both countries. To promote further development of pediatric medical devices in the future, improvements to expediting the review process to approval by the regulatory body, global development, and implementation of alternative measures to ensure the efficacy and safety of the device instead of large-scale clinical trials should be anticipated through cooperation among industry, government, and academia.

Keywords: Pediatric medical device; Regulatory measure; Regulatory science.

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Conflict of interest statement

Authors have no conflicts of interest to declare. The views expressed in this article are those of the authors and do not necessarily reflect the official views of Pharmaceuticals and Medical Devices Agency (PMDA) or Japan’s Ministry of Health, Labour and Welfare (MHLW).

Figures

Fig. 1
Fig. 1
The number of approved brand-new medical devices in Japan from April 2006 to December 2019. *2 pediatric medical devices approved in 2018 are used for blocking blood flow to the acardiac fetus
Fig. 2
Fig. 2
History of supportive regulatory measures for pediatric medical device development in Japan and the United States
See this image and copyright information in PMC

References

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    1. Food and Drug Administration, CDRH Management Directory by Organization. https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTo.... Accessed June17, 2020.
    1. Pharmaceuticals and Medical Devices Agency, Approved brand-new medical devices in Japan, https://www.pmda.go.jp/review-services/drug-reviews/review-information/d...(in Japanese). Accessed June17, 2020.
    1. Ministry of Health, Labour and Welfare, Pharmaceuticals and medical devices. https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/i...(in Japanese). Accessed June17, 2020.
    1. Ministry of Health, Labour and Welfare, Study Group on the Early Introduction of Medical Devices, etc. with High Medical Need. https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000095066.html(in Japanese). Accessed June17, 2020.

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